上市中药品种临床精准定位“两维三阶”研究模式构建与实践

Construction and practice of’two-dimension and three-stage’research paradigm for precise clinical positioning of marketed traditional Chinese patent medicine

上市中药品种在临床应用中存在适应人群或疾病定位不清晰,疗效优势或结局指标不明确等问题,成为长期困扰中医药研究学者的共性研究难题。明确其临床定位是提升疗效证据级别、发挥中医药疗效优势、扩大患者健康获益的前提与关键。本团队针对该研究难题,构建了证据升级与证据外推有机融合、“系统评估-精准定位-高级证据”为核心的“两维三阶”研究模式。同时以松龄血脉康胶囊为典型案例,详细介绍如何整合文献证据与专家经验,发掘中药潜在疗效优势;如何利用真实世界研究实现临床精准定位;如何针对性优化临床试验方案,产生高级别临床证据;并重点论述该研究模式的整体框架、设计原则、实施要点。本研究为实现上市中药品种临床精准定位、获得高级别证据提供了一种创新研究模式与成功实践经验。

In clinical practice,there are many problems for the marketed traditional Chinese patent medicine including fuzzy indication and target population,unclear efficacy advantages,or outcome indicators.It has become a great challenge which long plagued the researchers in the field of TCM.Clarifying the clinical positioning of traditional Chinese patent medicine is the premise and key to improving the quality of efficacy evidence,giving full play to the advantages of TCM,and expanding the health benefits of patients.In response to this research problem,we constructed a’two-dimension and three-stage’paradigm,which consists of three elements including systematic assessment,precise positioning,high-quality evidence.This article takes the Songling Xuemaikang Capsule as a case,and focuses on how to integrate literature evidence and expert experience to explore the potential therapeutic advantages of traditional Chinese patent medicine,how to achieve accurate clinical positioning based on real-world research data,how to optimize the trial protocol and generate high-quality evidence,and focus on the framework,design principle,and implementation.This study provides an innovative paradigm and successful case for achieving precise clinical positioning of marketed traditional Chinese patent medicine varieties and obtaining high-level evidence.